RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

K221062 · Bionime Corporation · QRL · Sep 26, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221062
• Device Name: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
• Applicant: Bionime Corporation
• Product Code: QRL · General, Plastic Surgery
• Decision Date: Sep 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device. GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device. iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

Device Story

Mechanical, reusable lancing device; holds and fires single-use lancets linearly to prick skin for capillary blood collection. User-adjustable depth (7 levels: 0.5mm to 1.7mm) via adjustable cap. Features clear cap for alternative site testing (palm/forearm). Includes lancet ejection mechanism to prevent sharps injury. Operated by single patient; intended for home/OTC use. Provides blood sample for glucose monitoring or other diagnostic tests. Benefits patient by enabling safe, controlled, and adjustable capillary blood sampling.

Clinical Evidence

Bench testing only. Includes ISO 10993-5 (cytotoxicity), ISO 10993-23 (skin irritation), and ISO 10993-10 (skin sensitization) testing. Functional validation and cleaning/disinfection testing performed.

Technological Characteristics

Mechanical lancing device; 7-level depth adjustment (0.5mm-1.7mm); manual loading/firing mechanism; includes clear cap for alternative site testing; single-patient use; biocompatible materials per ISO 10993 standards.

Indications for Use

Indicated for single-patient use by individuals requiring capillary blood sampling for glucose monitoring or other tests requiring 1-2 drops of blood. Compatible with sterile lancets; supports fingertip and alternative site (palm/forearm) testing.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) *Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) *Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) *Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class III (premarket approval).(3) *Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• On Call Lancing Device (K113332)
• Genteel Lancing Device (K153670)

Submission Summary (Full Text)

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September 26, 2022

Bionime Corporation % I Hsin Li Regulatory Consultant Symbiosis Consulting Ltd. 11F., No.95, Sec. 2, Nanjing E. Rd., Zhongshan Dist., Taipei, 10489 Taiwan

Re: K221062

Trade/Device Name: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL Dated: August 26, 2022 Received: August 26, 2022

Dear I Hsin Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221062

Device Name BIONIME CORPORATION

## Indications for Use (Describe)

#### RIGHTEST Lancing Device GD500

RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

### GE Lancing Device

GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

### iGlucose Lancing Device

iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K221062

# SECTION 5-510(k) SUMMARY

This 510 (K) summary is being submitted in accorndance with requirements of
ithe 21,CFR Section 807.92.

| A. | 510(k) NUMBER | K221062 |
|--------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. | DATE PREPARED | September 25th, 2022 |
| C. | SUBMITTER | BIONIME CORPORATION<br>NO. 100, Section 2, Daqing Street., South District,<br>Taichung City, Taiwan, 40242<br>Registration Number: 3004183148<br>FEI Number: 3004183148<br>Tel: [phone] |
| D. | CONTACT PERSON | Primary Contact Person<br>Engineer<br>Name: Yu Chi Huang<br>Tel: [phone]#5898<br>E-mail: [e-mail]<br><br>Second Contact Person<br>Regulatory Consultant<br>Name: I Hsin Li<br>Tel: [phone]<br>E-mail: [e-mail] |
| E. | DEVICES | Proprietary Name: RIGHTEST Lancing Device GD500<br>Common Name: Multiple Use Blood Lancet For Single Patient Use Only<br>Product Code: QRL<br>Regulation Number: 21 CFR 878.4850<br>Device Class: Class II<br>Review Panel: General & Plastic Surgery<br><br>Proprietary Name: GE Lancing Device<br>Common Name: Multiple Use Blood Lancet For Single Patient Use Only<br>Product Code: QRL<br>Regulation Number: 21 CFR 878.4850<br>Device Class: Class II<br>Review Panel: General & Plastic Surgery |
| Proprietary Name: | iGlucose Lancing Device | |
| Common Name: | Multiple Use Blood Lancet For Single<br>Patient Use Only | |
| Product Code: | QRL | |
| Regulation Number: | 21 CFR 878.4850 | |
| Device Class: | Class II | |
| Review Panel: | General & Plastic Surgery | |

SECTION 5-510(k) SUMMARY Page 1 of 8 pages

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RIGHTEST Lancing Device GD500 F. INDICATION(S) FOR

USE

RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

## GE Lancing Device

GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

## iGlucose Lancing Device

iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

SECTION 5-510(k) SUMMARY Page 2 of 8 pages

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| G. | PRIMARY<br>PREDICATE DEVICE | Proprietary Name:<br>Common Name:<br>Product Code:<br>Regulation Number:<br>510(k) Number:<br>510(k) Submitter:<br>Device Class:<br>Review Panel: | On Call Lancing Device<br>Single Use Only Blood Lancet with An<br>Integral Sharps Injury Prevention Feature<br>FMK<br>21 CFR 878.4850<br>K113332<br>ACON Laboratories Inc.<br>Class II<br>General & Plastic Surgery |
|----|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| H. | SECONDARY<br>PREDICATE DEVICE | Proprietary Name:<br>Common Name:<br>Product Code:<br>Regulation Number:<br>Regulation Name:<br>510(k) Number:<br>510(k) Submitter:<br>Device Class:<br>Review Panel: | Genteel Lancing Device<br>Single Use Only Blood Lancet with An<br>Integral Sharps Injury Prevention Feature<br>FMK<br>21 CFR 878.4850<br>Blood lancets<br>K153670<br>Genteel LLC<br>Class II<br>General & Plastic Surgery |
| I. | DEVICE DECRIPTION | | RIGHTEST Lancing Device GD500/ GE Lancing Device/<br>iGlucose Lancing Device is a mechanical device holding and<br>firing a single-use lancet linearly ahead to prick the skin to<br>collect capillary whole blood from target sites. RIGHTEST<br>Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing<br>Device can be adjusted for 7 levels of depth for a user collecting<br>different amount of capillary blood. |
| J. | COMPARISON OF<br>TECHNOLOGICAL<br>CHARACTERISTICS<br>WITH THE<br>PREDICATE DEVICES | | RIGHTEST Lancing Device GD500, GE Lancing Device and<br>iGlucose Lancing Device and predicate devices (K113332 and<br>K113618) are:<br>1. Same "intended use/ indication(s) for use"<br>2. Same "Puncture device to obtain micro blood<br>samples"<br>3. Same "Clear cap for testing alternative site"<br>4. Same "Lancet retracted after use to prevent sharp<br>injure"<br>5. Same "Mechanical loading and firing function"<br>6. Same "Ejecting the used lancet Without touching the<br>used disposable lancet"<br>7. Different "The depth of penetration" |

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## K221062

## RIGHTEST Lancing Device GD500/GE Lancing

Device/iGlucose Lancing Device and predicate devices (K113332 and K153670) are all the same intended use/ indication(s) for use, intended population, similar technical design and functions. The varying setting in the depth of penetration between RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device and predicate devices did not raise other concerns on safety and efficacy.

BIONIME CORPORATION concluded that RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670).

# SECTION 5-510(k) SUMMARY

Page 4 of 8 pages

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# K. A COMPARISON TABLE WITH PREDICATE DEVICES

| Items | Proposed Device<br>RIGHTEST Lancing Device GD500,<br>GE Lancing Device and iGlucose<br>Lancing Device | Primary Predicate Device<br>On Call Lancing Device | Secondary Predicate<br>Device<br>Genteel Lancing Device | Substantial<br>Equivalence<br>Comparison<br>Assessment |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| 510(k) Number | TBD | K113332 | K153670 | N/A |
| Product Code | QRL | FMK | FMK | Different |
| Device<br>Classification | Class II | Class II | Class II | Same |
| Intended Use/<br>Indication(s) for Use | RIGHTEST Lancing Device<br>GD500 is a reusable lancing<br>device for the single user. It<br>should be used with the proper<br>sterile lancet for the capillary<br>blood sampling. It could<br>automatically inject the lancet<br>into and retract it from the<br>fingertip to obtain a capillary<br>blood sample for glucose<br>monitoring or other test that<br>require one or two drops of<br>blood. A depth adjustable cap<br>allows the best depth of skin<br>penetration for each individual<br>user. Alternative site testing<br>(palm or forearm) can be<br>performed by installing the clear<br>cap on the lancing device.<br><br>GE Lancing Device is a reusable<br>lancing device for the single<br>user. It should be used with the | The On Call® Lancing Device is<br>used with On Call® disposable<br>sterile lancets to draw capillary<br>blood from the fingertip, palm (at<br>the base of the thumb) or forearm,<br>for blood glucose testing or other<br>testing utilizing small amounts of<br>blood. The On Call® Lancing<br>Device is intended to be used by a<br>single patient and should not be<br>shared. | The Genteel lancing<br>device is used with<br>disposable sterile<br>lancets to draw<br>capillary blood<br>from the fingertip or<br>alternate sites for<br>blood glucose<br>testing or other<br>testing utilizing<br>small amounts of<br>blood. The Genteel<br>lancing device is for<br>Single Patient Use<br>Only. | Same |

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| K22 | 11 | 062 |
|-----|----|-----|
| | | |

| Items | Proposed Device | Primary Predicate Device | Secondary Predicate Device | K22106<br>Substantial<br>Equivalence<br>Comparison<br>Assessment |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------|
| | RIGHTEST Lancing Device GD500,<br>GE Lancing Device and iGlucose<br>Lancing Device | On Call Lancing Device | Genteel Lancing Device | |
| | proper sterile lancet for the<br>capillary blood sampling. It<br>could automatically inject the<br>lancet into and retract it from the<br>fingertip to obtain a capillary<br>blood sample for glucose<br>monitoring or other test that<br>require one or two drops of<br>blood. A depth adjustable cap<br>allows the best depth of skin<br>penetration for each individual<br>user. Alternative site testing<br>(palm or forearm) can be<br>performed by installing the clear<br>cap on the lancing device. | | | |
| | iGlucose Lancing Device is a<br>reusable lancing device for the<br>single user. It should be used<br>with the proper sterile lancet for<br>the capillary blood sampling. It<br>could automatically inject the<br>lancet into and retract it from the<br>fingertip to obtain a capillary<br>blood sample for glucose<br>monitoring or other test that<br>require one or two drops of<br>blood. A depth adjustable cap<br>allows the best depth of skin | | | |
| Items | Proposed Device<br>RIGHTEST Lancing Device GD500,<br>GE Lancing Device and iGlucose<br>Lancing Device | Primary Predicate Device<br>On Call Lancing Device | Secondary Predicate<br>Device<br>Genteel Lancing Device | Substantial<br>Equivalence<br>Comparison<br>Assessment |
| | penetration for each individual<br>user. | | | |
| Puncture device to<br>obtain micro blood<br>samples | Yes | Yes | Yes | Same |
| Clear cap for testing<br>alternative site | Yes | Yes | Yes | Same |
| Lancet retracted<br>after use to prevent<br>sharp injure | Yes | Yes | Yes | Same |
| Mechanical loading<br>and firing function | Yes | Yes | Yes | Same |
| Ejecting the used<br>lancet Without<br>touching the used<br>disposable lancet | Yes | Yes | Yes | Same |
| The depth of<br>penetration | 7 different depths<br>The settings of penetration depths are<br>0.5 mm, 0.7 mm, 0.9 mm 1.1 mm, 1.3<br>mm, 1.5 mm and 1.7 mm. | 6 different depths | six interchangeable<br>contact tips | Different |
| OTC/Rx | OTC | OTC | OTC | Same |
| Design | Image: RIGHTEST Lancing Device GD500, GE Lancing Device and iGlucose Lancing Device design | Image: On Call Lancing Device design | Image: Genteel Lancing Device design | Similar<br>design |

## SECTION 5-510(k) SUMMARY

Page 6 of 8 pages

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K221062

SECTION 5-510(k) SUMMARY

Page 7 of 8 pages

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#### L. SUMMARY OF PERFORMANCE DATA

The following performance data were provided to demonstrate the safety and efficacy:

- ISO 10993-5 In vitro Cytotoxicity A.
- ISO 10993-23 Skin Irritation B.
- C. ISO 10993-10 Skin Sensitization (Maximization Test)
- D. Functional tests were validated and completed.
- E. The cleaning and disinfections on the materials of device were evaluated and tested.
- M. SUBSTANTIAL EQUIVALENCE CONCLUSION

BIONIME CORPORATION concludes that the RIGHTEST Lancing Device GD500/GE Lancing Device/iGlucose Lancing Device is substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns.

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